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Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk

Sponsor: Aktiia SA

NCT ID: NCT06670677

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
Mostly remote — few or no hospital visits
Drug or intervention
Lifestyle survey completion (other), Unlimited on-demand blood pressure measurements with G2C (other), Continual blood pressure measurements with G1 (other)
How long the study runs
Study runs about 120 months (dates as stated)
About the drug or intervention
Lifestyle survey completion — other: For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. · Unlimited on-demand blood pressure measurements with G2C — other: For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated · Continual blood pressure measurements with G1 — other: For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at whether the Aktiia blood pressure monitor, a bracelet-like device, helps people spot high blood pressure (hypertension) early and predict their risk of heart and circulation problems. It is being run by Aktiia SA, the company that makes the device. People aged 21 to 85 living in Switzerland, Germany or the UK may be able to take part.

Who can take part

  • Adults aged 21 to 85
  • People living in Switzerland, Germany or the UK
  • People who already use Aktiia and own a smartphone with either Apple (iOS) or Android software, or people who do not use Aktiia but own one of these smartphones
  • People willing and able to follow the study procedures

Who may not be able to

  • People with ongoing heart rhythm problems, such as a very fast resting heart rate (over 120 beats per minute) or atrial fibrillation (an irregular heartbeat)
  • People with conditions that reduce blood flow to the hands and fingers, such as Raynaud's disease, diabetes, kidney problems, untreated over- or under-active thyroid, a rare tumour called pheochromocytoma, or an abnormal connection between an artery and a vein
  • People with nerve damage affecting many nerves (polyneuropathy)
  • People who are pregnant
  • People with broken or injured skin on the wrists or index fingers
  • People with an amputated index finger or an amputated arm
  • People under 21 or over 85 years old

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team. The study involves using a bracelet device and a smartphone, but details of visits and duration are not stated.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
21 Years to 85 Years
Who
All
Number of participants
15,000
Started
2025-05-12
Last checked
2025-05

Plain English Summary

What is this study?

  • • Testing a new treatment for hypertension
  • • Clinical study - 15,000 participants
  • • Because Aktiia S

Who can take part?

  • • Ages 21 Years to 85 Years
  • • Diagnosed with hypertension

Where?

  • • London - Fully remote study- no physical investigational site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Because Aktiia S.A. has been the first-ever company to put in the market an Optical Blood Pressure Monitoring device, there is a need for Aktiia S.A. to correlate for the first time continual Blood Pressure monitoring and the evolution of environmental and health factors to improve hypertension management.

More detail

ARM 1: N1\~ 3'300 subjects. Research participants are Aktiia G1 users with Android operating system, i.e. individuals who already purchased the Aktiia G1 device out of the context of the study, located in Switzerland, Germany or UK, and owning a smartphone with Android operating system. ARM 1 research participants are asked to: * For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project, * For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. * Additionally, once the Aktiia One App is released and for the next 10 years: * Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated. ARM 2: N2\~ 6'600 subjects. Research participants are Aktiia G1 users with iOS operating system, i.e. individuals who already purchased the Aktiia G1 device out of the context of the study, located in Switzerland, Germany or UK, and owning a smartphone with iOS operating system. ARM 2 research participants are asked to: * For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project, * For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum. * Additionally, once the Aktiia One App is released and for the next 10 years: * Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated. ARM 3: N3\~ 5'000 subjects. Research participants are non-Aktiia-G1 users (they do not own an Aktiia G1 device at their inclusion in the study), located in Switzerland, Germany or UK, and owning a smartphone with either iOS or Android operating system. ARM 3 research participants are asked to: * For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum. * At their inclusion in the study: download the Aktiia One App to access G2C functionality with on-demand measurements at fingertip using the smartphone's camera. * For the next 10 years, starting at their inclusion in the research project and thereafter: * Take unlimited on-demand measurements with the Aktiia G2C feature.

HypertensionCardiovascular RiskBlood Pressure Check (Hypertension Screening)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 21 Years - 85 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Adult subjects aged 21 to 85 years old
  • ✓Subjects living in Switzerland, Germany or in the UK
  • ✓Subjects that are:
  • ✓Aktiia users owning a smartphone with either iOS or Android operating system (ARMs 1 and 2); or Aktiia non-users...
  • ✓Subjects agreeing to follow the study procedures.

Who cannot take part

  • ✗Subjects suffering from sustained heart arrhythmias that can lead to weak or unstable pressure pulses including...
  • ✗Subjects suffering from polyneuropathy;
  • ✗on pregnant women;
  • ✗Subjects with damaged / injured skin at the wrists (for bracelet measurements) or at index fingers (for camera...
  • ✗Subjects with amputated index fingers (for camera measurements) or amputated upper limb;
See the full criteria
Inclusion Criteria: 1. Adult subjects aged 21 to 85 years old 2. Subjects living in Switzerland, Germany or in the UK 3. Subjects that are: Aktiia users owning a smartphone with either iOS or Android operating system (ARMs 1 and 2); or Aktiia non-users owning a smartphone with iOS or Android operating system (ARM 3) 4. Subjects agreeing to follow the study procedures. Exclusion Criteria: 1. Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including resting tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation; 2. Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 30mL / min / 1.73 m2), untreated hyper-/ hypothyroidism, pheochromocytoma, or arteriovenous fistula; 3. Subjects suffering from polyneuropathy; 4. on pregnant women; 5. Subjects with damaged / injured skin at the wrists (for bracelet measurements) or at index fingers (for camera measurements) 6. Subjects with amputated index fingers (for camera measurements) or amputated upper limb; 7. Subjects below 21 years old and above 85 years old.

Where Is This Study? (1 UK site)

Fully remote study- no physical investigational site

London, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Pascale Vermare

Sponsor contact

CONTACT

+41 32 552 20 52 pascale.vermare@aktiia.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-05